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Doans Backache Pills

Document: spc-doc_PL 17907-0444 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Doans Backache Pills

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients: Paracetamol BP 150mg

Sodium Salicylate BP 100mg

3    PHARMACEUTICAL FORM

Tablets

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of rheumatic aches and pains, including backaches sprains lumbago, fibrositis, muscular aches and pains.

4.2 Posology and method of administration

Route of administration: Oral.

Adults: 2 or 3 tablets every 4 hours. Do not take more than 16 tablets in any 24 hour period.

Children: Do not give to children under 16 years, unless specifically indicated (e.g. Kawasaki’s disease).

4.3 Contraindications

Doans Backache Pills should not be given to patients suffering from peptic ulceration, gout or haemophilia Doans Backache Pill should not be used in patients hypersensitive to sodium salicylate, aspirin or paracetamol and/or other constituents.

4.4 Special warnings and precautions for use

Use with caution in asthmatic patients.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

The hazards of overdose are greater in those with non- cirrhotic alcoholic liver disease. Do not exceed the recommended dose. The labels will say: Do not take with any other paracetamol containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

The leaflets will say: Immediate medical advice should be sought in the event of an overdose even if you feel well because of the risk of delayed serious liver damage.

If symptoms persist, consult your doctor. Keep out of the reach of children. There is a possible association between aspirin and Reye's Syndrome when given to children. Reye’s Syndrome is a very rare disease which affects the brain and liver and can be fatal. For this reason it should not be given to children under 16, unless specifically indicated (e.g. Kawasaki’s disease).

4.5 Interaction with other medicinal products and other forms of interaction

Paracetamol- potentiation may occur with the coumarin anticoagulants. Interactions with cholestyramine and metoclopramide have also been reported, reducing absorption of the former and potentiating the action of the latter.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding occasional doses have no significant effect.

The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by Cholestyramine.

Salicylates - may enhance the effect of anticoagulants and inhibit the uricosuric effect of probenecid, they can also potentiate metoclopramide. Antacids in large doses may reduce plasma concentrations by hastening renal excretion of sodium salicylate.

4.6 Fertility, Pregnancy and lactation

There is epidemiological evidence of the safety of paracetamol in human pregnancy used in the recommended dosage but the patient should follow the advice of their doctor regarding its use. There is clinical and epidemiological evidence of the safety of aspirin in human pregnancy, but it may prolong labour and contribute to maternal and neo-natal bleeding and so it is best avoided during the last 3 months of pregnancy. In view of inadequate evidence of safety for Doans backache pills, the product should be used with caution during pregnancy and lactation. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data on paracetamol does not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Side effects with Doans backache pills are rare in therapeutic doses. Paracetamol has been widely used and reports of adverse reactions are rare and are generally associated with overdosage. Hypersensitivity including skin rash may occur. Isolated cases of thrombocytopenic purpura, methaemoglobinaemia, agranulocytosis, nausea and vomiting have been reported. Isolated cases of chronic hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported after overdosage or prolonged administration. Salicylates may induce hypersensitivity, asthma, urate kidney stones, gastro-intestinal irritation, acute and chronic gastro-intestinal blood loss, tinnitus, nausea and vomiting.

4.9 Overdose

Overdose should be immediately treated by inducing emesis and gastric lavage. Vital functions should be monitored and supported.

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Overdose should be immediately treated by inducing emesis and gastric lavage. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning hepatic failure may progress to encephalopathy, coma and death. However, it should be noted that patients who have taken an overdose of paracetamol may appear well for the first three days then succumb with liver damage. The hepatic changes produced by overdosage of paracetamol result from the accumulation of a highly reactive intermediate metabolite in the hepatocytes. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias, pancreatitis and death have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of toxic metabolites (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Immediate treatment is essential in the management of paracetamol overdosage. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for urgent medical attention and any patient who had ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measured must be available.

Overdosage with salycilates may produce dizziness, tinnitus, vasodilatation, sweating nausea and vomiting contusion and hyperventilation. Gross overdosage may lead to CNS depression with coma, cardiovascular collapse and respiratory depression. If overdosage is suspected, the patient should be kept under observation for at least 24 hours, as symptoms and salicylate blood levels may not become apparent for several hours. Treatment of overdosage consists of gastric lavage and forced alkaline diuresis. Haemodialysis may be necessary in severe cases.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Sodium Salicylate is an inhibitor of prostaglandin synthetase and acts as a non-steroidal anti-inflammatory analgesic drug.

Paracetamol is an analgesic acting on the central nervous system.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.

Sodium salicylate, like aspirin, is absorbed in the stomach, but probably at a greater rate than aspirin. Acetysalicylates and salicylates are also readily absorbed from the intestine, but this may be reduced in the case of sodium salicylate by the concomitant administration of alkalis.

Hydrolysis to salicyclic acid occurs rapidly in the intestine and in the circulation. Salicylates are extensively bound to plasma proteins. Salicylates are rapidly distributed to all body tissues; they appear in milk and cross the placenta. The rate of excretion of salicylates varies with the pH of the urine, increasing as the pH rises and being greatest at pH 7.5 and above. Salicylates are excreted as salicyclic acid and as glucoronide conjugates and as salicyluric and gentisic acids.

5.3 Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Core

Microcrystalline cellulose Sodium starch glycollate Colloidal anhydrous silica Magnesium stearate Stearic acid

Film Coat

Hydroxypropyl methyl cellulose Polysorbate 80

Opaspray green M-I-3888B (E171,E172,E464) Purified talc

6.2 Incompatibilities

None.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Child resistant blister packs made of 250pm white opaque rigid UPVC backed with 15pm PVC / 20pm aluminium foil.

Pack size: 8,16.

6.6 Special precautions for disposal

Medicines should be kept out of the reach of children.

7 MARKETING AUTHORISATION HOLDER

Bristol Laboratories Limited

Unit 3, Canalside, Northbridge road

Berkhamsted

Herts

HP4 1EG

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 17907/0444

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

2nd February 2005

10 DATE OF REVISION OF THE TEXT

25/07/2012